Archive for MHRA Updates
Class 3 Medicines Recall: Neuraxpharm UK Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg Capsules, EL(24)A/19
Source: MHRA / Gov.uk 5.6.24 Neuraxpharm UK Ltd is recalling specific batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after...
Class 4 Medicines Defect Information: Manx Healthcare Ltd., Betamethasone Valerate 0.1% Ointment, EL(24)A/18
Source: MHRA/ Gov.uk 3.6.24 Manx Healthcare Ltd. has informed MHRA that they have identified a problem with the product packaging of the batch indicated in the table. MDR number MDR...
Class 4 Medicines Defect Information: Fresenius Kabi Limited, Sodium Chloride 0.9% Intravenous Infusion BP (Freeflex and Freeflex Plus), EL (24)A/17
Source: MHRA / Gov.uk 22.5.24 Fresenius Kabi Limited have informed the MHRA of a packaging error with specific batches of Sodium Chloride Intravenous Infusion 0.9% Freeflex and Freeflex PLUS. MDR...
Class 3 Medicines Defect Information: Doncaster Pharma Limited, Keppra 500mg film-coated tablets, EL(24)A/15
Source: MHRA / Gov.uk 22.5.24 The MHRA has re-issued this notification as Class 3 recall based on further assessment. Please note the new actions for healthcare professionals listed within the...
Class 4 Medicines Defect Information: Doncaster Pharma Limited, Keppra 500mg film-coated tablets, EL(24)A/15
Source: MHRA / Gov.uk 15.5.24 Doncaster Pharma Limited have identified an error relating to the Braille printed on the cartons on various parallel imported packs which have been repackaged by...
Class 3 Medicines Recall: Neon Healthcare Ltd, Suprefact 1 mg/ml solution for injection
Source: MHRA /Gov.uk 23.4.24 (Cheplapharm – Canadian Livery), EL(24)A/14: Neon Healthcare Ltd is recalling the specific batch mentioned in this notification as a precautionary measure. MDR number MDR 191-04/24 Company...
Symbios ORIGIN® Posterior Stabilised Patient-Matched Total Knee Replacement Device
Source: MHRA/Gov.uk 23.4.24 Risk of Early Revision, DSI/2024/005 The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with...
Class 3 Medicines Recall: Accord-UK Ltd, Co-Codamol 8/500mg Effervescent Tablets
Class 3 Medicines Recall: Accord-UK Ltd, Co-Codamol 8/500mg Effervescent Tablets (Key Pharmaceuticals Livery), EL (24)A/12 Source: MHRA / Gov.uk 10.4.24 Accord-UK Ltd is recalling a specific batch of Co-Codamol 8/500mg...
Class 3 Medicines Recall: Bristol-Myers Squibb Pharmaceuticals Limited,
Source: MHRA/Gov.uk 4.4.24 Class 3 Medicines Recall: Bristol-Myers Squibb Pharmaceuticals Limited, OPDIVO 10 mg/mL concentrate for solution for infusion (nivolumab), EL(24)A/11 Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that...
Counterfeits and unbranded copies of LifeVac anti-choking devices
Counterfeits and unbranded copies of LifeVac anti-choking devices may fail to work correctly or worsen choking incidents if used, DSI/2024/003 Source: MHRA / Gov.uk 25.3.24 Anti-choking devices are intended to...
Class 4 Medicines Notification: Fresenius Kabi Limited,
Sodium Chloride Intravenous Infusion 0.9% Freeflex, EL (24)A/10 Source: MHRA / Gov.uk 21.3.24 Fresenius Kabi Limited has informed the MHRA of an error on the infusion bag packaged into the...
Class 3 Medicines Recall: Besins Healthcare (UK) Ltd
Source: MHRA / Gov.uk 19.3.24 Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol), EL (24)A/09. Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two...